Cerebral InfarctionICONSNCT01429948
Identification the Cause of Silent Cerebral infarctiON in Healthy Subjects (ICONS)
An observational study of Cerebral Infarction, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
We hypothesized that paradoxical embolism may be one of the main mechanisms of silent cerebral infarction (SCI) located outside the perforating artery territory. In the present study, we evaluated the association between SCI and paradoxical embolism detected by agitated saline transcranial Doppler (TCD) monitoring in… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cerebral Infarction
- How many people
- 581 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary Hospital
Who may be able to join
- Healthy subjects
- Subjects with age over 20 years
- Subjects who consecutively visited a health promotion center for a health screening examination that included routine laboratory test, cardiac work-ups (12-lead electrocardiography and/or echocardiography), and brain magnetic resonance image (MRI) and MR angiography (MRA)
- Subjects who showed silent brain infarction (SCI) which was defined as a focal hyperintensity lesion 3 mm or large in diameter in the fluid-attenuation inversion recovery (FLAIR) images without a history of a corresponding stroke or transient ischemic attack (TIA)
- Subjects who performed agitated saline transcranial Doppler (TCD) monitoring
- Patients with acute stroke (both cryptogenic embolic stroke and conventional stroke mechanisms)
Show all 10Show fewer
- Patients with age over 20 year
- Patients with focal neurologic deficits presented within 7 days of symptom onset
- Patients with acute ischemic lesions on diffusion-weighted image (DWI)
- Patients who performed agitated saline TCD monitoring
Who cannot join
- Healthy subjects
- Subjects with the presence of previous history of stroke or TIA
- Subjects with the presence of dementia on history taking or mini-mental status examination
- Subjects with the presence of proximal source of embolism, including atrial fibrillation or significant (≥50%) stenosis on cervicocerebral artery on MRA or carotid Duplex
- Subjects who had SCI restricted within perforator territory (basal ganglia or pons) suggesting that microangiopathy rather than embolism could be the main mechanism of SCI
- Subjects in whom agitated saline TCD monitoring was not performed or those who had poor temporal windows
- Patients with acute stroke (both cryptogenic embolic stroke and conventional stroke mechanisms)
- Patients in whom agitated saline TCD monitoring was not performed or those who had poor temporal windows
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University
Seoul, 135710
About this study
Official title: Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke
We hypothesized that paradoxical embolism may be one of the main mechanisms of silent cerebral infarction (SCI) located outside the perforating artery territory. In the present study, we evaluated the association between SCI and paradoxical embolism detected by agitated saline transcranial Doppler (TCD) monitoring in healthy subjects without history of stroke or transient ischemic attack (TIA). We also compared the frequency and amount of paradoxical embolism between healthy subjects with SCI and acute stroke patients with presumed cryptogenic embolism or conventional stroke mechanisms.
- Conditions
- Cerebral Infarction
- Keywords
- Stroke, Ischemic, Patent foramen ovale, Magnetic resonance imaging, Paradoxical embolism, Transcranial Doppler, Silent cerebral infarct
- Medical subject headings
- Cerebral Infarction, Ischemic Stroke, Foramen Ovale, Patent, Embolism, Paradoxical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Healthy subjects with silent cerebral infarction | |
| Control group 1 | Patients with acute cryptogenic embolic stroke | |
| Control group 2 | Patients with acute stroke with conventional stroke mechanisms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring
Measured: Within a month after MRI scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startApr 2008
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oh Young Bang, MD, PhD, Principal investigator, Samsung Medical Center, Sungkyunkwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429948
- Sponsor's protocol ID
- 2008-02-046
- Acronym
- ICONS
- Status last verified
- Sep 2011
- First submitted
- 6 Sep 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SJ, Shin HY, Ha YS, Kim JW, Kang KW, Na DL, Bang OY. Paradoxical embolism as a cause of silent brain infarctions in healthy subjects: the ICONS study (Identification of the Cause of Silent Cerebral Infarction in Healthy Subjects). Eur J Neurol. 2013 Feb;20(2):353-60. doi: 10.1111/j.1468-1331.2012.03864.x. Epub 2012 Sep 9.
PubMed 22958084
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers for Personalized Therapy in Korean Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01429948
- Acronym / sponsor ID
- ICONS / 2008-02-046
- Conditions
- Cerebral Infarction
- Keywords
- Stroke, Ischemic, Patent foramen ovale, Magnetic resonance imaging, Paradoxical embolism, Transcranial Doppler, Silent cerebral infarct
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesized that paradoxical embolism may be one of the main mechanisms of silent cerebral infarction (SCI) located outside the perforating artery territory. In the present study, we evaluated the association between SCI and paradoxical embolism detected by agitated saline transcranial Doppler (TCD) monitoring in healthy subjects without history of stroke or transient ischemic attack (TIA). We also compared the frequency and amount of paradoxical embolism between healthy subjects with SCI and acute stroke patients with presumed cryptogenic embolism or conventional stroke mechanisms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –Healthy subjects with silent cerebral infarction |
| Control group 1 | – | –Patients with acute cryptogenic embolic stroke |
| Control group 2 | – | –Patients with acute stroke with conventional stroke mechanisms |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary Hospital
Key inclusion criteria (10 listed)
- Healthy subjects
- Subjects with age over 20 years
- Subjects who consecutively visited a health promotion center for a health screening examination that included routine laboratory test, cardiac work-ups (12-lead electrocardiography and/or echocardiography), and brain magnetic resonance image (MRI) and MR angiography (MRA)
- Subjects who showed silent brain infarction (SCI) which was defined as a focal hyperintensity lesion 3 mm or large in diameter in the fluid-attenuation inversion recovery (FLAIR) images without a history of a corresponding stroke or transient ischemic attack (TIA)
- Subjects who performed agitated saline transcranial Doppler (TCD) monitoring
Key exclusion criteria (8 listed)
- Healthy subjects
- Subjects with the presence of previous history of stroke or TIA
- Subjects with the presence of dementia on history taking or mini-mental status examination
- Subjects with the presence of proximal source of embolism, including atrial fibrillation or significant (≥50%) stenosis on cervicocerebral artery on MRA or carotid Duplex
- Subjects who had SCI restricted within perforator territory (basal ganglia or pons) suggesting that microangiopathy rather than embolism could be the main mechanism of SCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring
Time frame: Within a month after MRI scanning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
- Derived from this study: PubMed 22958084Kim SJ, Shin HY, Ha YS, Kim JW, Kang KW, Na DL, Bang OY. Paradoxical embolism as a cause of silent brain infarctions in healthy subjects: the ICONS study (Identification of the Cause of Silent Cerebral Infarction in Healthy Subjects). Eur J Neurol. 2013 Feb;20(2):353-60. doi: 10.1111/j.1468-1331.2012.03864.x. Epub 2012 Sep 9.
Related trials for Cerebral Infarction
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oh Young Bang, MD, PhD principal investigator
Samsung Medical Center, Sungkyunkwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarction, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and amount of right-to-left shunts (RLS) on agitated saline TCD monitoring (time frame: Within a month after MRI scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01429948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.